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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214787

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VEKLURY (REMDESIVIR)
100MG/VIAL
Marketing Status: Prescription
Active Ingredient: REMDESIVIR
Proprietary Name: VEKLURY
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 100MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214787
Product Number: 001
Approval Date: Oct 22, 2020
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VEKLURY (REMDESIVIR)
100MG/20ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: REMDESIVIR
Proprietary Name: VEKLURY
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/20ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214787
Product Number: 002
Approval Date: Oct 22, 2020
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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